Evidence map›Paper›PMID 31409292›Full record

Trial reportBMC neurology2019

Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN).

Li Shen Loo, Brian M Plato, Ira M Turner, Michael G Case, Joel Raskin, Sherie A Dowsett, John H Krege

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02439320 phase3completednot on this map

A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2016Enrolled2,231ConditionsAcute MigraineArmsLasmiditan 100 mg, Lasmiditan 200 mg, Placebo (matches lasmiditan doses)
NCT02605174 phase3completednot on this map

A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2017Enrolled3,005ConditionsMigraine With or Without AuraArmsLasmiditan 50 mg, Lasmiditan 100 mg, Lasmiditan 200 mg, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. The 5-HTNature reviews. Neurology · 2023
    Review
  6. Article
  7. Review
  8. Review
  9. Ditans: a new prospective for the therapy of migraine attack?Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Review
  10. Review
  11. Lasmiditan: Acute Migraine Treatment Without Vasoconstriction. A Review.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2021
    Review
  12. [Primary headaches : Neglected or overrated?]Schmerz (Berlin, Germany) · 2020
    Article
  13. The potential of lasmiditan in migraine.Therapeutic advances in neurological disorders · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Li Shen LooEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA. loo_li_shen@lilly.com.
Brian M PlatoNorton Neuroscience Institute, 3991 Dutchmans Ln #310, Louisville, KY, 40207, USA.
Ira M TurnerThe Center for Headache Care and Research, Island Neurological Associates PC, An affiliate of ProHealthcare, 824 Old Country Rd, Plainview, NY, 11803, USA.
Michael G CaseEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
Joel RaskinEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
Sherie A DowsettEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
John H KregeEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
Eli Lilly (United States) · USNorton Healthcare · USProHealth Care · US

Funding

Eli Lilly and Company The SPARTAN and SAMURAI studies were sponsored by CoLucid Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company.
6 · The paper itself

Abstract

backgroundWe studied the efficacy and safety of a second dose of lasmiditan for acute treatment of migraine.

methodsSAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies in which individuals with migraine were randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo. Study drug was to be taken within 4 h (h) of onset of a migraine attack (moderate or severe pain). A second dose of study drug was provided for rescue (patient not pain-free at 2 h and took a second dose 2-24 h post-first dose) or recurrence (patient pain-free at 2 h, but experienced recurrence of mild, moderate, or severe migraine pain and took a second dose 2-24 h after first dose). Randomization to second dose occurred at baseline; patients originally assigned lasmiditan were randomized to the same lasmiditan dose or placebo (2:1 ratio), and those originally assigned placebo received placebo. Data from SAMURAI and SPARTAN were pooled for efficacy and safety assessment of a second dose of lasmiditan.

resultsThe proportion of patients taking a second dose was lower with lasmiditan versus placebo, and decreased with increasing lasmiditan dose; the majority who took a second dose did so for rescue. In patients taking lasmiditan as first dose, outcomes (pain free, most bothersome symptom [MBS] free) at 2 h after a second dose for rescue were similar whether the second dose was lasmiditan or placebo (p > 0.05 in all cases). In patients taking lasmiditan for first dose, outcomes at 2 h after a second dose for recurrence were as follows: lasmiditan pooled versus placebo - pain free, 50% vs 32% (p > 0.05); MBS free, 71% vs 41% (p = 0.02); pain relief, 77% vs 52% (p = 0.03). In patients whose first dose was lasmiditan, the incidence of treatment emergent adverse events (TEAEs) reported after the second dose was similar whether second dose was lasmiditan or placebo.

conclusionsA second dose of lasmiditan showed some evidence of efficacy when taken for headache recurrence. There was no clear benefit of a second dose of lasmiditan for rescue treatment. The incidences of TEAEs were similar whether the second dose was lasmiditan or placebo.

trial registrationSAMURAI ( NCT02439320 ) [April 2015]. SPARTAN ( NCT02605174 ) [May 2016].

Indexed as

AdultBenzamidesDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPiperidinesPyridinesRecurrenceSerotonin Receptor AgonistsBenzamideslasmiditanPiperidinesPyridinesSerotonin Receptor AgonistsLasmiditanPhase 3RecurrenceRescueSecond dose

Identifiers

PMID31409292
PMCPMC6691529
OpenAlexW2968453666

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.